Philip Payne
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The assembly of the World Health Organisation (WHO) later this month is expected to feature counterfeit medicines as one of
its important discussion points, and there is some hope that the ministers will agree on measures that will strengthen anticounterfeiting
legislation and enforcement worldwide.
Few people in the pharmaceutical industry need convincing of the danger counterfeit medicines pose to public health and commercial
profit. Sadly, the world's politicians seem somewhat oblivious to the arguments, and there are many countries where counterfeit
medicines are openly marketed or where the production of counterfeit medicines is either treated as no crime at all or something
worthy of only minor punishment.
The most recent meeting of the International Medical Products Anti-Counterfeiting Taskforce (IMPACT), which took place in
Lisbon (Portugal) last December, endorsed a document of principles and elements that may prove to be the precursor for international
cooperation in enacting national legislation against counterfeit medical products.
IMPACT's impactIMPACT was created by WHO in 2006 from a global coalition of stakeholders, including industry, regulatory and law enforcement
representatives. Its remit was to forge international collaboration in combating counterfeit medicinal products and to raise
awareness of related issues. Five working groups were established to specifically examine the issues and potential approaches
offered by legislation, regulatory implementation, enforcement, technology and communication.
According to IMPACT, its stakeholders have surveyed national and international legislative instruments and, while further
study is necessary, a number of key issues have been identified as contributory factors in the increasing prevalence of counterfeit
pharmaceuticals:
- The definition of counterfeit medical products is absent or inadequate.
- Counterfeiting medical products is not considered a serious crime or, in some cases, not even a crime.
- If counterfeiting medical products is considered a crime, sanctions are sometimes more lenient than those for counterfeiters
of products that have no health implications (e.g., t-shirts).
- Sanctions are not applicable unless it is proven that counterfeits have resulted in injuries or death.
- The responsibilities of those involved in the distribution system are not clearly defined.
- There are no provisions for effective coordination and information exchange among various authorities and other stakeholders
at national, regional and international levels.
- There are no provisions that allow authorities to share information nationally, regionally or internationally, or to use information
obtained by others in legal proceedings.
- There are no provisions addressing the problem of trade in packaging and labelling materials without the obvious involvement
of the companies whose name appears on these materials.
- There are insufficient legal provisions concerning the confiscation and use of assets, equipment and other materials used
in conjunction with the manufacture, trade and transportation of counterfeit products.
The author says...
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Based on these considerations, IMPACT prepared and endorsed a document of principles and elements designed to assist member
states in establishing, complementing or updating national and regional legislations regarding counterfeit pharmaceuticals.
In doing so, IMPACT specifically excluded some commercial considerations, such as intellectual property, parallel importation
and theft of counterfeit products, to restrict its focus primarily to public and personal health implications.
Combined effort
While accepting that all stakeholders can help combat counterfeit pharmaceuticals, IMPACT claims that the primary role rests
with governments, and has created an extensive list of measures that governments must address to protect public health. These
include recommendations on drawing up legislation and defining activity that should be seen as illegal and, additionally,
suggesting sanctions for those illegal acts. A key element of IMPACT's argument is that the manufacture of counterfeit medicinal
products should be punished with equal severity whether the product has damaged anyone's health or not.
Alongside these recommendations to governments, IMPACT also outlines the key responsibilities for manufacturers and distributors
— particularly in complying with existing laws, GMP and good distribution practice (GDP). Technological solutions to the problem
often have a limited benefit as some jurisdictions have limited access to appropriate technology and, where it does exist,
it is expected to result in increased prices. There is even an argument that technological solutions can raise more problems
than they solve.
